Health coaching in primary health care for older people at moderate risk for cardiovascular diseases (CVD), diabetes and depression

ISRCTN	ISRCTN01396033
DOI	https://doi.org/10.1186/ISRCTN01396033
Secondary identifying numbers	N/A

Submission date: 21/10/2011
Registration date: 24/11/2011
Last edited: 09/08/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The aim of this study is to improve the health of older people at moderate risk for cardiovascular disease, diabetes or depression, by using health coaching and subsequent activities to promote a better lifestyle and help them live longer and healthier lives.

Who can participate?
Men and women aged 60 to 75 who are at moderate risk for cardiovascular disease, diabetes or depression

What does the study involve?
Participants are randomly allocated to either the intervention group or the control group. Both groups receive standard primary health care. Participants in the intervention group also receive motivational talks from a health coach that encourage them to improve their lifestyle. All participants undergo medical tests and complete questionnaires at the start of the study and after 6, 12 and 18 months. The intervention group and the control group are compared to find out whether there are any differences regarding blood pressure, blood sugar, depression, waist circumference, quality of life and lifestyle. The cost effectiveness of the intervention is also assessed.

What are the possible benefits and risks of participating?
All participants are informed about the results of their medical tests and the intervention group may benefit from the motivational talks. There are no risks involved in this study.

Where is the study run from?
21 primary health care centers in Sweden. The study is managed by Umeå University (Sweden).

When is the study starting and how long is it expected to run for?
October 2011 to June 2013

Who is funding the study?
Swedish National Institute of Public Health (Sweden)

Who is the main contact?
Prof. Lars Lindholm
lars.lindholm@epiph.umu.se

Contact information

Prof Lars Lindholm
Scientific

Epidemiologi and Global health
Umeå University
Umeå
SE 910 85
Sweden

Email	lars.lindholm@epiph.umu.se

Study information

Study design	Randomized controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Health coaching in primary health care for older people at moderate risk for CVD, diabetes and depression: a randomized controlled trial in Sweden to promote healthier lifestyle with physical activity, better food and improved social life
Study objectives	One goal in the Swedish public health policy is to give young older people the possibility to live a long and healthy life. The overall aim of this study is to promote a better life style in order to live longer and healthier. The specific objectives are: 1. To give municipalities and county councils better knowledge of how they together with the informal sector can promote healthy aging 2. To increase the opportunities for older persons with moderate risk levels to get better health through health coaching conducted with motivational interviewing and subsequent activities. The following research questions are in focus: 2.1. Are there some differences between the intervention group and the control group regarding health related quality of life? 2.2. Are there some differences between the intervention group and the control group regarding medical variables and self-reported lifestyle patterns? 2.3. Is the intervention cost effective?
Ethics approval(s)	The Regional Ethical Review Board in Umeå, 16/08/2011, ref: Dnr 2011-230-31
Health condition(s) or problem(s) studied	Moderate risk for CVD, diabetes and depression in older people
Intervention	The study will compare patients which receive standard primary health care and patients that get standard care plus motivational talks (MI) that encourage the individuals to improve their lifestyle. The method is often referred to as MI (motivational interviewing) and will be conducted at baseline and after 3, 6, 12, and 18 month. 75% of the 2000 participants will be randomized to the intervention group and the rest will a control group receiving standard care. This implies that each county will recruit 500 participants of which 125 are randomized to the control group.
Intervention type	Behavioural
Primary outcome measure	1. Blood pressure level at baseline and after 6, 12 and 18 months 2. Blood sugar level (Hba1c) at baseline and after 6, 12 and 18 months 3. Depression according to Montgomery-Asberg Depression Scale (MADRS) self rating scale at baseline and after 6, 12 and 18 months 4. Waist circumference in cm at baseline and after 6, 12 and 18 months
Secondary outcome measures	A questionaire with general and health related questions. 1. Section A- Background questions 2. Section B- Your social life 3. Section C- Life style questions 4. Section D- General health related questions including questions on drug use 5. Section E- EQ5D - including the Visual Analogue Scale (VAS) scale 6. Section F- Montgomery-Åsberg Depression Rating Scale (MADRS) scale on depression
Overall study start date	01/10/2011
Completion date	30/06/2013

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	2000 (1500 in the intervention group and 500 in the control group)
Key inclusion criteria	Men and women between 60 and 75 are recruited to the study at the primary health care centre. Four counties in Sweden are selected and within these counties 21 health care centers have agreed to participate. All of them will enroll participants that fulfill one or more of the four individual inclusion criteria. 1. A minor increase of blood pressure that is not treated with drugs 2. A minor increase of blood sugar that is not treated with drugs 3. A minor depression that is not treated with drugs 4. An increase of waist-circumference
Key exclusion criteria	Participant uses drugs linked to the inclusion criteria
Date of first enrolment	01/10/2011
Date of final enrolment	30/06/2013

Locations

Countries of recruitment

Sweden

Study participating centre

Umeå University

Umeå
SE 910 85
Sweden

Sponsor information

Swedish National Institute of Public Health (Sweden)
Government

Forskarens väg 3
Östersund
SE 83140
Sweden

Email	sara.wamala@fhi.se
Website	http://www.fhi.se/en/
"ROR"	https://ror.org/05x4m5564

Funders

Funder type

Government

Swedish National Institute of Public Health (Sweden)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	06/03/2013		Yes	No

Editorial Notes

09/08/2016: Plain English summary added.